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Trial record 69 of 284 for:    impact | "Fibromyalgia"

Combined Behavioral and Analgesic Trial for Fibromyalgia (COMBAT-FM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01598753
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Dennis Turk, University of Washington

Tracking Information
First Submitted Date  ICMJE May 1, 2012
First Posted Date  ICMJE May 15, 2012
Last Update Posted Date November 1, 2018
Study Start Date  ICMJE May 2012
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
30% improvement in daily diary pain intensity ratings or 20% improvement in the 9-item function subscale of the Fibromyalgia Impact Questionnaire Revised (FIQR). [ Time Frame: Baseline is one week prior to drug titration. Post treatment is assessed the week following final treatment ]
The primary outcome is the change in pain severity measured by the average of 5-days of daily pain diaries, or a change in score of the function subscale of the FIQR, assessed just prior to and at the end of treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2012)
Change in mean pain severity derived from 5-days of daily pain diaries and change in physical function assessed from the Fibromyalgia Impact Questionnaire-Revised (FIQ-R). [ Time Frame: Baseline is one week prior to drug titration. Post treatment is assessed the week following final treatment ]
The primary outcome is the change in pain severity measured by the average of 5-days of daily pain diaries assessed just prior to and at the end of treatment.
Change History Complete list of historical versions of study NCT01598753 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Behavioral and Analgesic Trial for Fibromyalgia
Official Title  ICMJE Phase 3 Double Blind Randomized Study Comparing Drug Treatment (Tramadol Versus Placebo) and Behavioral Health Treatments (Cognitive Behavioral Therapy Versus Health Education) for Patients With Fibromyalgia
Brief Summary

This is a randomized control study that involves a combination of a drug treatment, behavioral health, and placebo controls.

Some participants will receive a medication approved by the Food and Drug Administration for treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive an inactive pill, called a placebo. There will also be 2 different types of behavioral health treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which have been recommended for the treatment of patients with FM by the American Pain Society.

There are 4 possible study treatment combinations:

  1. Tramadol + CBT,
  2. Tramadol + HE,
  3. Placebo + CBT,
  4. Placebo + HE.

Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there have been no studies that have evaluated the combination of medication and a behavioral health treatment. The primary purpose of this study is to compare the benefits of the 4 combinations listed.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: Tramadol

    50 mg tablets titrated up to 2 tablets four times per day for a maximum dose of 400mg per day.

    Minimum accepted dose of 200mg per day

  • Drug: Placebo
    Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg
  • Behavioral: Cognitive Behavior Therapy for FM
    Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.
  • Behavioral: Health Education
    Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia
Study Arms
  • Active Comparator: Tramadol
    Intervention: Drug: Tramadol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Cognitive Behavior Therapy for FM
    Intervention: Behavioral: Cognitive Behavior Therapy for FM
  • Sham Comparator: Health Education
    Intervention: Behavioral: Health Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2018)
228
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2012)
250
Actual Study Completion Date July 31, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and Females 21-70
  • Diagnosis of Fibromyalgia
  • Current primary care physician
  • Fluent in English

Exclusion Criteria:

  • Rheumatologic disorders
  • Drug and alcohol abuse in the past year
  • Psychiatric hospitalization in the past 6 months
  • Current use of Tramadol
  • Certain antidepressant and other pain medications
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01598753
Other Study ID Numbers  ICMJE STUDY00001259
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dennis Turk, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Washington
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP